Kornimate/medical-research-clean huggingface dataset:
effectiveness of anti-il-5/il5r inhibitors

Conditions: Severe Asthma

Summary: the goal of this observational study is to assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an il5/il5r antagonists was initiated between 2012 and 2020. the main question\[s\] it aims to answer are: * what is the response rate after one year of treatment with il5/il5r antagonists. * what is the response and remission rate after one year of treatment with il5/il5r antagonists in subjects who fullfilled the original randomized control trials (rcts) inclusion criteria compared with those who did not.

il5/il5-receptor (il5r) antagonists are effective in reducing asthma exacerbations and have a corticosteroid sparing effect in selected severe eosinophilic asthmatics. the original randomized clinical trials that assessed the efficacy of il5/il5-r antagonists included highly selected patients who are not necessarily representative of the asthmatic population treated with il5/il5r antagonists in clinical practice. the aims of this study are: 1. to assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an il5/il5r antagonists was initiated between 2012 and 2020. 2. to compare the response and remission rate after one year of treatment with il5/il5-r antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials. we will perform a retrospective cohort study using data from the hospital charts of severe asthmatics treated with mepolizumab, reslizumab or benralizumab between november 2012 and december 2020 at the outpatient asthma clinic of a tertiary center (sacre-coeur hospital) in montreal. cohort entry (ce) will be defined as the first prescription filled of il5/il5r antagonists. authorization from the research ethics committee of the ciusss du nord-de-l'île-de-montréal and from the director of professional services was obtained. statistical analysis descriptive statistics will be used to summarize clinical, functional, and demographic characteristics of the patients of the whole cohort, as well as of the rct in group and rct out group. baseline data will be recorded on the date closest to cohort entry. results will be expressed as mean and standard deviation, except for data with a non-normal distribution, which were expressed as median and interquartile ranges and proportions for categorical variables. chi-squared test and student's t test will be used to compare patients' characteristics between rct in group and rct out group. all tests will be two-tailed, and the statistical significance level will be set at 0.05. logistic regression analyses will be performed to identify factors associated with a positive response to treatment as well as the achievement of remission on treatment.

Eligibility criteria:
inclusion criteria: all patients 18 years and older diagnosed with severe asthma in whom an il5/il5r antagonist was initiated at the outpatient asthma clinic of a tertiary center (sacre-coeur hospital) in montreal.c between 2012 and 2020. exclusion criteria: none

Keywords: severe asthma il5 antagonist
correlation between thoracic kyphosis posture and static balance

Conditions: Kyphosis; Balance; Distorted; Postural Kyphosis; Spine Disease; Balance

Summary: the effects of balanced posture and postural changes have been evaluated in specific populations with different factors that can affect body postures and balance, such as age, musculoskeletal system, and other metabolic diseases. studies on postural kyphosis and balance involvement are very few in the literature especially in the health population. of the few studies that have evaluated kyphosis and balance, most are limited by small sample size and the exclusion of men. many have focused primarily on the geriatric population. the determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. the aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance.

background: kyphosis is roughly a slight forward curvature of the spine. a slight kyphosis or posterior curvature is normal throughout the human body and is present in every individual. hyperkyphotic is a kyphotic angle greater than 40° commonly measured on a lateral x-ray measured by the cobb method between c7 and t12. postural stability or balance is the ability to keep the center of mass within the boundaries of the support base. moving the center of mass beyond the boundaries of the support base may cause postural instability and loss of balance. there are studies showing that kyphotic posture affects the center of gravity and affects fall in the elderly, but there are limited studies on the effect of balance in young individuals. the aim of this study is: to study the correlation between the balance and severity of thoracic kyphosis will be investigated

Eligibility criteria:
inclusion criteria: * adults aged 18 and over willing to attend the study. * for those who join the thoracic kyphosis group, individuals with a kyphosis angle ≥ 40 degrees. * individuals with a kyphosis angle \< 40 degrees for the control group. exclusion criteria: * spine trauma, surgery, bone pathology, arthritis etc. have a history of illness kyphotic deformity types are rounded back, scheuermann's disease, hunched back, flat back and dowager hump. * any spinal deformity, bone abnormality, postural deformity and disc herniation with / without peripheral symptoms. * body mass index (bmi), which is an indicator of obesity, is more than \> 30. * complaining of balance problems, coordination problems, other neurological or vestibular diseases that affect body balance and posture. * having any orthopedic or neurological disease that affects the body joints or the integrity of the musculoskeletal system. * use of any medication that can cause dizziness or drowsiness in the last months.
creation of a multicenter national registry for peripartum cardiomyopathy.

Conditions: Peripartum Cardiomyopathy

Summary: peripartum cardiomyopathy (ppcm) is a rare, severe and potentially life-threatening disorder of largely unknown etiology and pathophysiology, with unexplained geographical differences and heterogeneous presentation. investigators hypothesize that a network-based multidisciplinary strategy integrating clinical and molecular phenotyping of ppcm patients might anticipate diagnosis, optimize treatments, and identify novel mechanisms to achieve the unmet goal of personalized medicine.

specific aims of this study are: a) to create a multicenter pilot registry of ppcm in different areas in italy to assess incidence and prevalence of this rare disease, associated comorbidities and risk factors. b) to deeply characterize identified ppcm patients through clinical, imaging, genetic, biochemical, and molecular phenotyping. c) to gain novel mechanistic information on ppcm by performing deep clinical and molecular phenotyping in available biobanks samples of patients with ppcm and healthy controls.

Eligibility criteria:
inclusion criteria * development of hf signs or symptoms in the last month of pregnancy or within 5 months of delivery; * left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria (lvef\< 45 %) in the last month of pregnancy or within 5 months of delivery. exclusion criteria * presence of any identifiable cause of hf; * presence of recognizable heart disease before the last month of pregnancy.
clinical outcomes of mega-dosage supplementations of cholecalciferol in critically ill patients with sepsis

Conditions: Critically Ill; Sepsis; Mortality Rate; Critical Care

Summary: non-covid-19 sepsis (sepsis) has always been one of the common diseases in critically ill patients. the main treatment strategy is to kill pathogens and mitigate hyperinflammation. one study demonstrated that the supplementation with 576,000 iu cholecalciferol (vitamin d3) as a single dose in critically ill adults in the medical intensive care units (micus) can improve clinical outcomes, including acute physiology and chronic health evaluation ii score (apache ii), sequential organ failure assessment score (sofa), and c-reactive protein (crp). it is a three-year, multi-center, prospective, parallel, double-blind, randomized controlled clinical trial for 240 eligible subjects, with administrations of vitamin d3 576,000 iu or placebo every 24 hours for 3 days (72 hours) within 96 hours after intensive care unit (icu) admission.


Eligibility criteria:
inclusion criteria: 1. medical subject ≥ 18 years old and diagnosed with sepsis 2. transferred to the intensive care unit within 24 hours after being diagnosed with sepsis 3. admitted to the icu with 40 \> apache ii score ≥ 15. 4. the intensivist anticipates that the subject will stay in the icu ≥ 7 days. exclusion criteria: 1. diseases that affect serum levels of 25(oh)d and calcium, including thyroidectomy, parathyroid disease, rickets, or severe cirrhosis \[child c\] 2. received large doses of vitamin d3 in the past four weeks (\> 2000 iu per day or ≥ 10,000 iu in a single dose) 3. admitted to the icu with diagnosis of covid-19 4. aids subjects taking immunosuppressants 5. organ transplant 6. active cancer 7. tuberculosis, sarcoidosis, or kidney stones in the past one year 8. weight \ 90 kg 9. had been admitted to icu in the past three months 10. subject and family members who do not speak the native language 11. pregnant women

Keywords: vitamin d cholecalciferol sepsis
evaluate women after vaginal surgery for urinary symptoms and sexual function

Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Surgery

Summary: assess the outcomes of vaginal surgeries and its impact on sexual function and urinary symptoms.

currently, up to 43% of women in the united states have female sexual dysfunction (fsd). in a recent study of 109 sexually active women in a urogynecology practice, fsd was noted using the validated female sexual function index (fsfi) in 64% of the women. difficulties with sexual function are also associated with pelvic organ prolapse and urinary incontinence. one in nine women will have surgery for incontinence or prolapse in her lifetime. the impact of vaginal surgeries on sexual function and urinary symptoms has been scarcely reported in the literature. the methodology of most of those studies is flawed by the use of questionnaires that were not validated, small sample sizes and no comparison control group. in addition, several studies only focused on one surgical intervention, specific types of incontinence or prolapse, or both. it is difficult to make sense out of the discordant research findings when applying it to our patient population. this is a prospective study of women with incontinence or pelvic organ prolapse. subjects will be selected from three urology practices. all patients will be asked to complete a short patient history form. if the woman meets the study criteria, the study will be explained and if she agrees to participate in this study, informed consent will be obtained. she will then complete the fsfi, sf-12 and pfdi-20 questionnaires.

Eligibility criteria:
inclusion criteria: * women at least 18 years of age * having urinary incontinence or pelvic organ prolapse * capable of giving informed consent * capable and willing to follow all study related procedures exclusion criteria: * reported history of urethral obstruction (not secondary to prolapse), stricture, bladder calculi or bladder tumor in the last 2 years. * pregnant as confirmed by urine pregnancy test or plans to become pregnant during the study period. * breast feeding * currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function * cannot independently comprehend and complete the questionnaires. * the subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination.

Keywords: vaginal incontinence sexual function
clinical evaluation of cardiac output estimation based on pulse wave transit time

Conditions: Myocardial Infarction; Myocardial Ischemia

Summary: the specific aim of this study is to assess whether a device approved by the fda to measure pulse oximetry can accurately estimate cardiac output.

we will compare three methods for measuring cardiac output: escco, pac, and ecom. cardiac output is an important physiological parameter that must be monitored closely during surgery and during an intensive care unit (icu) stay. the use of a pulmonary artery catheter (pac) has been the gold standard for accurate cardiac output (co) measurement. this method requires a catheter to be inserted into the pulmonary artery and cardiac output is indicated by the speed that a temperature gradient dissipates. while the use of the pulmonary artery catheter is widespread, inserting the pulmonary artery catheter is risky, time consuming and requires a high level of skill. for these reasons, new devices have been developed to measure cardiac output. a second method typically used is called ecom (endotracheal cardiac output monitor). a device is inserted into the patient's throat that calculates cardiac output by measuring how electricity moves through the patient's chest. the third method, estimated continuous cardiac output (escco), uses sensors placed on the patient's finger, arm and chest to calculate pulse wave transit time (pwtt); the time it takes for the heart beat pulse to travel through the patient's body. the escco system is fda approved for safety and efficacy to measure noninvasive blood pressure and pulse oximetry. the purpose of this study is to assess whether the pstt calculation provides a cardiac output measure that is comparable to the other methods. this study is sponsored by nihon kohden corporation who owns and manufactures the escco system.

Eligibility criteria:
inclusion criteria: * patients undergoing surgery where cardiac output will be measured with pac and ecom. exclusion criteria: * failure to obtain consent.

Keywords: cardiac output pulse oximetry hemodynamics
sacral neuromodulation with interstim® therapy for intractable urinary voiding dysfunctions (sounds): an observational study

Conditions: Urinary Incontinence; Over Active Bladder; Urinary Retention

Summary: the purpose of this study is to document the safety, the effectiveness, the continued performance at mid and long term, the morbidity and the percent of surgical revisions of the interstim® therapy for up to 5 years in a representative sample of french centers under real-life conditions of use.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years old; * patient signed the patient data release form; * patient suffering from retention or over active bladder; * patient is eligible for interstim® system therapy. exclusion criteria: * difficulty of collecting follow up patient data; * patient not affiliated to social security.
evaluation of dbt compared to drug counseling for opiate addicts

Conditions: Opiate Addiction; Borderline Personality Disorder

Summary: the purpose of this study is to compare a one year treatment program of dialectical behavior therapy (dbt) + suboxone for opiate addicted individuals meeting criteria for borderline personality disorder (bpd) to a one year program of standard drug counseling (i/gdc) + suboxone.

the purpose of this study is to compare a one year treatment program of dialectical behavior therapy (dbt) + suboxone for opiate addicted individuals meeting criteria for borderline personality disorder (bpd) to a one year program of standard drug counseling (i/gdc) + suboxone. drug counseling consists of manualized individual sessions + group therapy. this trial is being completed at two sites, at the university of washington and at duke university. one hundred and seventy-two individuals (86 per condition) with opiate dependence and meeting criteria for bpd will be enrolled in a one-year treatment and a one-year follow-up assessment. each site (university of washington, duke) will enroll 86 clients with both treatment conditions being conducted at each site. assessments measuring drug use, suicidal behaviors, retention and other treatment-related behaviors, general psychopathology and functioning, and increases in behavioral skills will be given at four month intervals for the entire two years.

Eligibility criteria:
inclusion criteria: * 1. meets scid-i criteria for opiate dependence. 2. meets ipde and scid criteria for bpd (dsm-iv) 3. over 18 years old 4. resides within commuting distance of treatment 5. consents to outpatient treatment for drug addiction exclusion criteria: * 1. bipolar, schizophrenia, schizophreniform, or schizoaffective disorders, psychosis nos 2. iq less than 70; life threatening anorexia; current and chronic absence of shelter; impending jail/prison for more than three weeks (problems which by their presence or severity preclude ability to attend or understand treatment and/or requires priority treatment over sud treatment) 3. court order to treatment, court order to treatment or to jail, or agency order to treatment or loss of child custody (due to consequent inability to freely drop-out of treatment) 4. is pregnant, plans to become pregnant during treatment phase, or becomes pregnant before random assignment to study condition 5. is unable to tolerate suboxone induction phase 6. is currently stable on methadone 7. current benzodiazepine use from which the participant is unwilling to taper 8. refuses: to discontinue current mental health or drug abuse treatment or random assignment.

Keywords: opiate dependence dbt dialectical behavior therapy drug counseling therapy, cognitive behavior
a novel classification for the assessment and grading of unexpected events in pediatric surgery: the clavien-madadi classification

Conditions: Complication of Surgical Procedure; Complication of Anesthesia; Complication,Postoperative; Complication of Medical Care

Summary: postoperative adverse events may be associated with substantial morbidity and mortality. however, inconsistent definitions of complications and unexpected events have limited accurate analysis of surgical outcomes. in 2004, the clavien-dindo classification for postoperative complications has been introduced and has since then been validated in numerous studies, with more than 20.000 citations. despite the appraisal of the clavien-dindo classification in the pediatric surgical literature, some criticize the transfer of grading systems for adults into a pediatric cohort without modification or validation. in a recent study we have shown that few items of the classification do not offer relevant information in pediatric cohorts and we have added organizational and management errors, not integrated in the initial proposal by dindo et al. especially, the variety of options for the management of complications based on institutional protocols and logistics is emphasized and a more focused and detailed assessment of the invasiveness of procedures in children is introduced.


Eligibility criteria:
inclusion criteria: * all patients with unexpected events within the study period, treated at the department of pediatric surgery (preterms - 17 years of age), hannover medical school exclusion criteria: * none;
utilization of somatic tissue oxygen saturation monitoring in pregnant women

Conditions: Pre-Eclampsia

Summary: the purpose of this study is to compare 3 methods of assessing endothelial function in healthy female volunteers and pregnant women with and without pregnancy induced hypertension. the methods under comparison are simultaneous tissue oxygen saturation (sto2), endopat and sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood pressure, 10 pregnant with hypertension) will be enrolled.

in both normotensive women and others with pregnancy induced hypertension, in previous research simultaneous tissue oxygen saturation (sto2) were measured in both forearms, with a blood pressure cuff above the tissue oximetry probe on one side. sto2 values were continuously monitored on each side during unilateral blood pressure (bp) cuff inflation (to suprasystolic pressure for 3 min), and then during deflation. despite similarity in the forearm sto2 decline observed with cuff inflation in all women, the rise following cuff deflation - indicative of reactive hyperemia - appeared reduced in hypertensive patients, suggesting a relationship with impaired endothelial reserve.

Eligibility criteria:
inclusion criteria: non-pregnant group: 1. \> 18 years of age 2. male or female pregnant group: 1. \> 18 years of age 2. pregnant women \> 20 weeks 3. diagnosis of pre-eclampsia characterized as systolic bp \> 140 mmhg, diastolic bp \> 90 mmhg after 20 weeks of gestation accompanied by new onset of proteinuria. 4. normotensive, not meeting criteria in #3 exclusion criteria: non-pregnant group: 1. raynaud's disease 2. adhesive tape allergy 3. recent myocardial infarction (\< 3 months) 4. congestive heart failure pregnant group: 1. raynaud's disease 2. adhesive tape allergy 3. recent myocardial infarction (\< 3 months) 4. congestive heart failure 5. hemodynamically unstable (sbp \< 90 mmhg) 6. fetal distress
routine minimally invasive thoracic surgery without aspirin withdraw

Conditions: Aspirin Sensitivity; Surgery

Summary: surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (asa). however, the perioperative management of these patients undergo non-cardiac surgery has not yet been clear. this single- arm study was to evaluate the safety of continuous use of asa in the perioperative period in routine minimally thoracic surgery.


Eligibility criteria:
inclusion criteria: 1. patients with stage i-iiia non-small-cell lung cancer underwent radical resection or other benign lung lesions need minimally invasive thoracic surgery; 2. vats and robotic surgery are both permitted; 3. cardio-pulmonary function can tolerate surgery. exclusion criteria: 1. cardio-pulmonary function couldn't tolerate surgery; 2. high bleeding risk after the pre- operative evaluation.

Keywords: aspirin minimally invasive thoracic surgery safety
pediatric metabolism and microbiome repository

Conditions: Pediatric Obesity

Summary: the aim of this project is to establish a bio-repository of diverse specimen types to provide investigators access to specimens in order to further research related to metabolism and the microbiome in the pediatric population.

human microbial cell lines, stool and/or dna and rna will be collected from participants 10-18 years with a bmi greater than 95th percentile and their healthy siblings. specimens will be collected at 3 time points over a seven month period. healthy siblings will provide just one blood and stool sample. samples will be maintained at the duke medical science research laboratory.

Eligibility criteria:
inclusion criteria: * patients of the healthy lifestyles program at duke for the care of children with obesity, a sibling of a patient in the healthy lifestyles program, or is a patient at duke children's primary care. exclusion criteria: * pregnant females.